Gaps #87411
openGaps #86698: HUMS T.H.I.S GAP Analysis
Gaps #87123: GAPS > CSSD > THIS
CSSD Module – Equipment Test Run Option
20%
Description
1. Description:
The system must provide an option to initiate and record a test run for sterilization/disinfection equipment in CSSD (e.g., autoclaves, washer disinfectors, low-temperature sterilizers) as part of routine quality assurance and maintenance. The test run verifies that equipment is functioning correctly before processing instruments or sets.
2. Functional Requirements:
o Initiate Test Run:
Provide a dedicated function/button in the CSSD module for “Equipment Test Run.”
Accessible only to authorized CSSD staff based on role permissions.
3. Mandatory Details to Capture:
o Equipment Type (e.g., Autoclave, Washer Disinfector, Low-Temperature Sterilizer) – selected from master list.
o Machine Number (unique identifier for the specific equipment unit).
o Operator/User ID (auto-captured from login).
o Test Number or ID (e.g., Bowie-Dick Test, Leak Test, Performance Qualification Test).
o Date & Time of Execution (system-generated).
4. Test Results Entry:
o Pass/Fail selection (radio buttons or drop-down).
o Comments/Remarks field (free text, mandatory for Fail result).
o Follow-Up Action flag (checkbox or drop-down for types of follow-up, e.g., Repair Request, Retest Scheduled).
5. Post-Test Workflow:
o If Pass, equipment is marked as available for use.
o If Fail, system should: Mark equipment as “Unavailable” until cleared.
Notify CSSD supervisor automatically.
Log follow-up action details.
6. Data Logging & Audit:
o Store all test run records with user, date/time, and results for compliance and traceability.
o Maintain historical log for at least the regulatory minimum retention period.
7. Reports:
o Equipment Test Run Log (filter by date, equipment type, machine number, test type, result).
o Failed Test Summary Report with follow-up action status.